Aniseed | whatsinit

About

What it is and where it shows up.

Aniseed is the dried fruit (cremocarp) of Pimpinella anisum, an aromatic annual herb of the Apiaceae family, valued for its distinctive liquorice-like flavour derived principally from trans-anethole. It is widely used as a spice, flavouring agent, and carminative in foods, confectionery, liqueurs, and herbal preparations.

Safety summary

The regulatory and scientific consensus.

Aniseed is recognised as GRAS by the US FDA when used at typical culinary levels as a spice or flavouring, and is approved in the EU under flavouring regulations with no established ADI. The primary active constituent, trans-anethole, is a phytoestrogen that is excreted into breast milk, and excessive maternal use of anise-containing herbal preparations has been linked to neonatal toxicity. Concentrated anise oil preparations (containing ≥1% estragole) are classified by EFSA as potentially genotoxic and carcinogenic, representing a hazard primarily at non-dietary/occupational exposure levels.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Approved as a flavouring substance and botanical spice under Regulation (EC) No 1334/2008 on flavourings. Anise oil and anise tincture authorised as sensory additives in animal feed under Regulation (EC) No 1831/2003. EMA recognises it as a traditional herbal medicinal product. EFSA flagged estragole content in anise oil as a genotoxic concern for concentrated preparations.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Permitted as a natural spice and flavouring (saunf) under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. May also be used in health supplements/nutraceuticals per Schedule II of the FSS (Health Supplements, Nutraceuticals) Regulations.source
FDA (Food and Drug Administration) (United States)	Approved	Listed as GRAS under 21 CFR 182.10 as a spice and natural seasoning; anise oil also GRAS under 21 CFR 182.20 as a natural flavouring substance. No maximum use level specified for culinary applications.source

Who should approach with care

Whose guidance would steer them away.

Lactation — Anethole is excreted into breast milk and excessive maternal intake of anise-containing herbal preparations has been associated with toxicity in breastfed newborns per the NIH LactMed database.

Infants — Excessive maternal anise consumption has been linked to neonatal anethole toxicity in breastfed infants; concentrated anise preparations should not be administered directly to infants.

Pregnancy — Trans-anethole is a phytoestrogen with potential hormonal activity; while culinary use is generally considered safe, medicinal or concentrated doses lack robust human safety data in pregnancy.

Other — Individuals with known allergy to plants in the Apiaceae/Umbelliferae family (e.g., celery, carrot, fennel) may experience cross-reactive hypersensitivity reactions to aniseed.

Research citations

The sources behind this verdict.

1FDA. Code of Federal Regulations Title 21, Part 182, Section 182.10 – Spices and Other Natural Seasonings and Flavourings. ecfr.gov
2PubMed. Anise – Drugs and Lactation Database (LactMed®), National Library of Medicine. ncbi.nlm.nih.gov
3other. Draft Assessment Report on Pimpinella anisum L. – European Medicines Agency (EMA). ema.europa.eu
4EFSA. Safety and Efficacy of Feed Additives from Pimpinella anisum L.: Anise Oil and Anise Tincture (EFSA FEEDAP Panel), 2023. pmc.ncbi.nlm.nih.gov
5PubMed. Review of Pharmacological Properties and Chemical Constituents of Pimpinella anisum, 2012. pmc.ncbi.nlm.nih.gov

Independently researched5 citations